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    • Regulatory Affairs Officer - Roodepoort - Greys Personnel

    Greys Personnel
    Greys Personnel Roodepoort

    1 week ago

    Greys Personnel background
    Description
    Location:
    Midrand

    Key Requirements:
    • Bachelor's degree in pharmacy.
    • 2-3 years of experience in Regulatory Affairs, preferably in orthodox human medicines.
    • Compliance with the Pharmacy Act (Act 53 of 1974) and the Medicines and Related Substances Act (Act No. 101 of 1965 as amended).
    • Demonstrable experience across product development, commercialization, and lifecycle management.
    • Knowledge of new and emerging Acts, Regulations, and Guidelines related to the pharmaceutical industry.
    • Experience with CTD software builder and eCTD application compilation is an advantage.

    Responsibilities:
    • Manage a portfolio of products allocated to you.
    • Participate in or coordinate all meetings related to the product portfolio and provide RA feedback to stakeholders.
    • Carry out special projects assigned by the RA Manager/Head of RA.
    • Ensure timely initiation and management of the registration process for new product submissions.
    • Complete specific pre-registration activities, including receipt, screening, compilation, and submission of dossiers to the Regulatory Authority.
    • Ensure approval of registration applications for all medicines with relevant authorities.
    • Maintain and update registrations according to relevant legislation, regulations, and guidelines.
    • Receive, prepare, and submit updates, variations, resolutions, and correspondence required by the Regulatory Authority.
    • Keep the Document Database up to date by completing administrative tasks for dossier maintenance, coordination, and accuracy.
    • Complete dossier audits of registered products.
    • Conduct dossier due-diligences and post-registration variations for applicable Regulatory Authorities.
    • Establish and maintain relationships with Regulatory Authorities for efficient application processing.
    • Prepare, review, and adhere to Standard Operating Procedures (SOPs) and local Regulatory Guidelines.
    • Stay informed about developments and changes in local and international regulatory environments impacting Adcock products.
    • Communicate these changes to relevant stakeholders to assess business impact.
    • Supervise and develop team members (RA Associates and RA Grad Students).
    • Ensure alignment of personal and company values.
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